Clinical Research Coordinator I/II

Responsibilities

• Coordinate and conduct clinical research study visits, including scheduling, participant interaction, and protocol-required procedures
• Recruit, screen, and enroll study participants, including obtaining informed consent and collecting medical history
• Collect and document clinical data, including vital signs, questionnaires, and study-related assessments
• Perform or support specimen collection and processing (e.g., blood draws, centrifugation) in accordance with protocol and licensure
• Maintain accurate and complete source documentation and case report forms in compliance with study requirements
• Support regulatory activities, including maintaining study files, preparing submissions, and ensuring audit readiness
• Ensure compliance with study protocols, institutional policies, and applicable regulations (e.g., GCP, FDA, IRB)
• Care for participants by coordinating participant care activities such as appointment scheduling, follow-up, and communication
• Prepare for and support study monitoring visits and audits
• Maintain professional and respectful communication with participants, investigators, and clinical staff
• Participate in quality control and process improvement efforts

Requirements

• Knowledge of clinical research practices, regulations, and terminology, including FDA, ICH, GCP, HIPAA, and IRB requirements
• Experience supporting clinical research activities such as participant recruitment, informed consent, data collection, and regulatory documentation
• Ability to ensure protocol compliance, data quality, and participant safety
• Familiarity with medical terminology and basic patient care procedures
• Strong organizational skills and attention to detail
• Experience with clinical equipment (e.g., centrifuge, EKG) preferred
• Medical Assistant, Phlebotomist, and Medical Assistant–Registered licensure required (may be obtained after hire)

Qualifications

• Minimum 1 year of full-time experience in clinical research, healthcare, or a related field
• Works under close to moderate supervision
• Supports study coordination activities across one or more protocols
• Developing knowledge of regulatory requirements, study procedures, and clinical trial operations
• Minimum 2+ years of clinical research experience with direct study coordination responsibilities
• Ability to independently manage studies or complex study components
• Strong working knowledge of regulatory processes and compliance requirements
• May provide guidance or informal mentorship to junior staff

Benefits

• Medical, dental, vision insurance
• Flexible spending accounts: health care, dependent care, commuter
• Short and long-term disability
• Life and AD&D insurance
• 403(b) retirement plan with matching funds after one year of employment
• PTO: 13 holidays, three weeks of vacation and two weeks of sick leave per year
• Employee assistance program
• Education assistance program
• Subsidized ORCA pass
• Wellness benefits
• Voluntary benefits